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AS ISO 10535

AS ISO 10535—2002

ISO 10535:1998

Australian Standard

Hoists for the transfer of disabled persons—Requirements and test methods

ISO 10535:1998 Australian Standard ™ Hoists for the transfer of disabled persons—Requirements and test methods

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This Australian Standard was prepared by Committee ME-067, Mobility Appliances for People with Disabilities. It was approved on behalf of the Council of Standards Australia on 25 June 2002 and published on 12 July 2002.

The following are represented on Committee ME-067:

Association of Consultants in Access Australa

Australian Association of Occupational Therapists

Australian Chamber of Commerce and Industry

Australian Committee of Independent Living Centres

Australian Industry Group

Certification Bodies (Australia)

The Commercial Vehicle Industry Association of Australia

Commonwealth Department of Veterans Affairs

Consumers Federation of Australia

Crippled Childrens Association

Federal Chamber of Automotive Industries

Flinders University of South Australia

Furntech

Institution of Engineers Australia

Paraplegic & Quadriplegic Association of N.S.W.

Paraplegic & Quadriplegic Association of Victoria

Queensland Health

Royal North Shore Hospital

Royal Perth Hosital

Technical Aid to the Disabled

The University of Melbourne

WorkCover New South Wales

Keeping Standards up-to-date Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about Standards can be found by visiting the Standards Australia web site at www.standards.com.au and looking up the relevant Standard in the on-line catalogue. Alternatively, the printed Catalogue provides information current at 1 January each year, and the monthly magazine, The Australian Standard, has a full listing of revisions and amendments published each month. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at mail@standards.com.au, or write to the Chief Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW

2001.

This Standard was issued in draft form for comment as DR 02231.

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AS ISO 10535—2002

Australian Standard™

Hoists for the transfer of disabled persons— Requirements and test methods

Originated as AS 2569.2—1987. Revised and redesignated as AS ISO 10535—2002.

COPYRIGHT

© Standards Australia International

All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher.

Published by Standards Australia International Ltd GPO Box 5420, Sydney, NSW 2001, Australia

ISBN 0 7337 4720 5

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ii

PREFACE

This Standard was prepared by Australian members of the Joint Standards Australia/Standards New Zealand Committee ME-067, Mobility Appliances for People with Disabilities to be used as a means to demonstrate compliance with the relevant essential principles in new medical device legislation.

After consultation with stakeholders in both countries, Standards Australia and Standards New Zealand decided to develop this Standard as an Australian, rather than an Australian/New Zealand Standard.

This Standard supersedes AS 2569.2—1987, Guide to the lifting and moving of patients, Part 2: Safe manual lifting and moving of patients.

This Standard is identical with and has been reproduced from ISO 10535:1998, Hoists for the transfer of disabled persons—Requirements and test methods.

The objective of this Standard is to specify general requirements and test methods for technical aids for disabled persons which are intended by the manufacturer to be medical devices.

This Standard provides for the use of the following Australian/New Zealand Standards as equivalents to particular ISO and CEN Standards referenced herein, as follows:

Reference to International Standard or European Standard

Australian/New Zealand Standard

EN

AS/NZS ISO

60601

Medical electrical equipment

3200

Medical electrical equipment

60601-1

Part 1: General requirements for safety

3200.1.0

Part 1.0: General requirements for safety—Parent Standard

60601-1-1-2

2. Collateral standard:

3200.1.2

Part 1.2: General requirements for

Electromagnetic compatibility—

Electromagnetic compatibility—Requirements and test methods

safety—Collateral Standard:

Requirements and tests

prEN

AS EN

12182

Technical aids for disabled persons—General requirements and test methods

12182

Technical aids for disabled persons— General requirements and test methods

ISO

AS/NZS

3758

Textiles—Care labelling code using symbols

1957

Textiles—Care labelling

As this Standard is reproduced from an International Standard, the following applies:

(a)

Its number does not appear on each page of text and its identity is shown only on the cover and title page.

(b)

In the source text ‘this European Standard’ should read ‘this Australian Standard’.

(c)

A full point substitutes for a comma when referring to a decimal marker.

The terms ‘normative’ and ‘informative’ have been used in this Standard to define the application of the annex to which they apply. A ‘normative’ annex is an integral part of a Standard, whereas an ‘informative’ annex is only for information and guidance.

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iii

CONTENTS

1

Scope

1

2

Normative references

1

3

Definitions

3

4

General requirements and test methods

5

4.1

General requirements

5

4.1.1

Risk analysis

5

4.1.2

Ergonomics factors etc.

5

4.1.3

Sound level

6

4.2

General test conditions

6

4.2.1

Test conditions

6

4.2.2

Test equipment

6

4.2.3

Tolerances

7

4.2.4

Test report

7

4.3

General safety requirements

7

4.4

Test methods for general safety requirements

9

4.5

Requirements for performance

11

4.6

Test methods for performance

11

4.7

Requirements for rate (velocity) of lifting and lowering

12

4.8

Test methods for rate (velocity) of lifting and lowering

12

4.9

Requirements for operating forces

12

4.10

Test methods for operating forces

12

4.11

Information supplied by the manufacturer

12

4.11.1

General

12

4.11.2

Marking

13

4.11.3

Instructions for use

13

4.12

Requirements for durability

14

4.13

Test methods for durability

14

5

Mobile Hoists - Specific requirements and test methods

15

5.1

Requirements for static strength

15

5.2

Test methods for static strength

15

5.3

Requirements for static stability

16

5.4

Test methods for static stability

16

5.5

Requirements for immobilizing device (brakes)

17

5.6

Test methods for immobilizing device (brakes)

17

5.7

Requirements for moving forces

17

5.8

Test methods for moving forces

17

5.9

Instructions for use

18

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iv

6

Stationary Hoists - Specific requirements and test methods

18

6.1

Specific safety requirements

18

6.2

Test methods for specific safety requirements

19

6.3

Requirements for static strength for all other stationary hoists

19

6.4

Requirements for static strength (free-standing stationary hoists only)

19

6.5

Test methods for static strength (free-standing stationary hoists only)

19

6.6

Requirements for static stability (free-standing stationary hoists only)

19

6.7

Test methods for static stability (free-standing stationary hoists only)

20

6.8

Requirements for static strength for all other stationary hoists

20

6.9

Test methods for static strength for all other stationary hoists

20

6.10

Instructions for use

21

7

Non-rigid body support units - Specific requirements and test methods

21

7.1

General

21

7.2

Requirements for the central suspension point

21

7.3

Test method for the central suspension point

21

7.4

Requirements for the spreader bar

21

7.5

Test methods for the spreader bar

22

7.6

Requirements for the non-rigid body support unit

22

7.7

Material and seams of the non-rigid body support unit

22

7.8

Test methods for non-rigid body support unit

22

7.9

Marking

23

7.10

Instructions for use

23

8

Rigid body support units - Specific requirements and test methods

23

8.1

General

24

8.2

Requirement for backrest

24

8.3

Requirements and test methods for durability

24

8.4

Marking

24

8.5

Instructions for use

25

9

Free-standing hoists for use in bath tubs

25

Figures

25

Annex A (Informative) -

Periodic inspection

32

Annex B (Informative) -

Applications

33

Annex C (Normative) - Hydraulic and pneumatic components

34

Annex ZZ (Normative) -

- requirements and test methods Corresponding International and European Standards for which

equivalents are not given in the text

36

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1

AUSTRALIAN STANDARD

Hoists for the transfer of disabled persons—Requirements and test methods

1 Scope

 
 

This European standard specifies requirements and test methods only for hoists and body support units intended for the transfer of disabled persons as classified in EN ISO 9999:1998:

 

12

36 03

Wheeled hoists with sling seats

12

36 06

Wheeled hoists with solid seats

12

36 09

Hoist trolleys

12

36 12

Stationary hoists fixed to the wall/walls, floor and/or ceiling

 

12

36 15

Stationary hoists fixed to, mounted in or on

 

another product

 

12

36 18

Stationary free standing hoists

12

36 21

Body-support units for hoists

 

This standard does not apply to devices that transports persons between two levels (floors) of a building.

 

This standard does not include methods for determination of ageing or corrosion of such hoists and units.

 

The requirements of this standard are formulated with regard to the needs of both the disabled persons being hoisted and the attendant using the hoist.

2 Normative references

 
 

This European standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies.

 

EN 292

Safety of machinery. Basic concepts, general principles for design

 

Part 1: Basic terminology, methodology Part 2: Technical principles and specification

 

EN 614-1

Safety of machinery. Ergonomic principles

 

Part 1: Terminology and general principles

 

EN 853

Rubber hoses and hose assemblies - Wire braid reinforced hydraulic type - Specification

 

EN 854

Rubber hoses and hose assemblies - Textile reinforced hydraulic type - Specification

Standards Australia

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